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A Study to Evaluate the Anti-emetic Effect of Aprepitant Versus Placebo as an Add-on Therapy in Children and Adolescent Receiving Chemotherapy: A Randomized, Doubly Blinded Controlled Trial

Phase 3
5 Years
18 Years
Open (Enrolling)
Chemotherapy Induced Nausea and Vomiting

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Trial Information

A Study to Evaluate the Anti-emetic Effect of Aprepitant Versus Placebo as an Add-on Therapy in Children and Adolescent Receiving Chemotherapy: A Randomized, Doubly Blinded Controlled Trial


Children and adolescents (5-18 years) with weight between 15-65 kg receiving highly
emetogenic chemotherapy (HEC) -

- VAC (vincristine, dactinomycin/Adriamycin, cyclophosphamide)

- ABVD (adriamycin, bleomycin, vinblastine, dacarbazine)

- Cisplatin/Doxorubicin

Sampling technique Subjects who met the eligibility criteria will be randomly assigned using
random allocation number generated by computer into one of the two groups. The unit of
randomization will be the subject at first cycle of HEC. The same patient will not be
enrolled for twice

Procedure for data collection:

1. The data will be collected from each patient from d1 to d10 of chemotherapy of which
patient will received chemotherapy in day care, maximum up to d3.

2. After taking consent patient will be enrolled as per inclusion and exclusion criteria,
and randomized to one of two groups. All baseline assessment will be done. Patient will
be explained about the filling of the diary. In first 2 days. The subjects will fill
the diary under the investigator supervision, and the rest of filling will be in home.
Reinforcement will be done over phone.

Procedure of double blinding

- Double blinding will be done for the intervention. Four different boxes will be made
for capsules. Total 3 capsules for 3 days will be made in a blister pack, mentioning
the d1, d2, d3 (for each capsule). Two different body weight groups will be made: 15-40
kg, and 41-65 kg.

- Group "A" will be the code for Aprepitant group and group "B" will be code for control
group. Both patient and the investigator will be blinded regarding medicine in the

Inclusion Criteria:

- All subjects must have a confirmed diagnosis of malignancy and receiving highly
emetogenic chemotherapy first time (VAC, ABVD and CDDP/Doxorubicin)

- Age group 5-18 years with weight between 15-65 kg

- Children/adolescents and their caregiver who can understand Hindi or English and
willing to participate in the study (with written informed consent)

Exclusion Criteria:

- Significant organ dysfunction

- Active infection

- Pregnancy

- Uncontrolled medical condition other than malignancy

- Need for contraindicated concomitant medication

- Patients receiving chemotherapy other than VAC, ABVD and CDDP/Doxorubicin

- Treatment with another investigational drug within 4 weeks of study start or prior
Aprepitant use

- Had received or will receive RT to abdomen or pelvis in the week prior to treatment

- Vomited in the 24 hr prior to treatment

- Prior exposure to highly emetogenic chemotherapeutics

- Abnormal lab values (ANC<1500/mm3, TLC<3000/mm3, Plt<100,000/mm3, AST/ALT> 2.5 times
of ULN, bill>1.5 times of ULN,>1.5 times of ULN, patient on systemic steroids

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

- Numbers of episodes of nausea and vomiting. - Duration of nausea (in hours). - Severity of nausea as per Edmonton's Symptom Assessment System (ESAS), numerical scale for nausea.

Outcome Time Frame:

5 days

Safety Issue:


Principal Investigator

Sameer Bakhshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dr. BRA IRCH, AIIMS, New Delhi (India)


India: Indian Council of Medical Research

Study ID:




Start Date:

August 2011

Completion Date:

June 2013

Related Keywords:

  • Chemotherapy Induced Nausea and Vomiting
  • Vomiting